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Data / Medical devices / China / Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd

Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd: FDA-registered device maker in Shanghai, China, 9 510(k) clearances

Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd is registered with the FDA (registration 3016705853) in Shanghai, China. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 28, 2016. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd
FDA registration number
3016705853
Address
F20,Tower1,Kerry Everbright City Enterprise Center No 128,West Tian my Road, Shanghai, China, 200070
Owner or operator
Cardinal Health 200, LLC (9028292)
Roles
Exporter to the US
First device listed
May 23, 1994
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Gown, Isolation, SurgicalFYC2Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Pump, Infusion, EnteralLZH2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 28, 2016K160339Cardinal Health Isolation GownFYCSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
May 21, 2015K150151SmartGownTM surgical gownFYASubstantially EquivalentCardinal Health 200, Inc.accessdata.fda.gov
March 4, 2015K142990Insta-Gard Surgical and Procedure Face MaskFXXSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
May 22, 2006K060649GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000FLLSubstantially EquivalentTyco Healthcare Group LPaccessdata.fda.gov
May 5, 2004K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSLZHSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
October 2, 2002K023167BREATHABLE SURGICAL GOWNFYASubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
March 18, 2002K020593CONVERTORS SMS POLYOLEFIN GOWNFYASubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
August 22, 2001K011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088FROSubstantially EquivalentThe Kendall Companyaccessdata.fda.gov
January 11, 2001K003313FILAC FAS TEMP ELECTRONIC THERMOMETERFLLSubstantially EquivalentThe Kendall Companyaccessdata.fda.gov

Compare with other makers

Updated July 28, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.